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XPRO America has emerged as a genuine, professional alternative to established USFDA compliance providers such as I3c global – I3CGLOBAL – Regulatory Consultants, particularly for organizations that want enterprise-level rigor without sacrificing responsiveness or value. The market for regulatory services has matured: clients now expect transparent scope, predictable timelines, and [...]
XPRO America has emerged as a genuine, professional alternative to established USFDA compliance providers such as Freyr Regulatory Services (Freyr USA), particularly for organizations that want enterprise-level rigor without sacrificing responsiveness or value. The market for regulatory services has matured: clients now expect transparent scope, predictable timelines, and consultative guidance [...]
Devices that emit radiation, including X-ray machines, lasers, ultrasound equipment, tanning lamps, and microwave ovens, are regulated by the FDA under 21 CFR Parts 1000–1050. Manufacturers, importers, and distributors must comply with strict registration, reporting, and safety requirements to ensure public health and avoid regulatory enforcement actions. At XPRO AMERICA, we provide end-to-end [...]
Human Cells, Tissues, and Cellular/Tissue-Based Products (HCT/Ps) are highly regulated by the FDA to ensure safety, quality, and traceability. Facilities that manufacture, process, store, or distribute HCT/Ps must comply with 21 CFR Part 1271 requirements, including registration, listing, adherence to Good Tissue Practices (GTP), and inspection readiness. At XPRO AMERICA, [...]
The U.S. Food Safety Modernisation Act (FSMA) is the most significant update to U.S. food safety laws in over 70 years. Its focus is clear: shifting from responding to food safety problems to preventing them. Companies that manufacture, process, pack, or store food for U.S. consumption must implement robust Food [...]
FDA compliance does not end after a product receives clearance or approval. Companies must actively manage post-market surveillance to ensure ongoing safety, effectiveness, and regulatory compliance. Failure to meet post-market obligations can lead to recalls, penalties, import alerts, and reputational damage. At XPRO AMERICA, we provide comprehensive post-market surveillance and [...]
For companies regulated by the U.S. Food and Drug Administration (FDA), compliance is not a one-time process but an ongoing responsibility. Each year, manufacturers, distributors, importers, and other regulated entities must renew their establishment registration and update product listings to remain in good standing with the FDA. In addition, regulatory [...]
In the highly regulated pharmaceutical and healthcare industry, compliance with the U.S. Food and Drug Administration (FDA) is not optional it is a business necessity. When drug products are found to be misbranded, adulterated, or unsafe, the FDA may require a recall or initiate enforcement actions. Mishandling a recall can [...]
For FDA-regulated industries such as food, cosmetics, dietary supplements, and pharmaceuticals, preparing for an FDA inspection is essential to ensure uninterrupted market access. Inspections are designed to verify compliance with U.S. Food and Drug Administration (FDA) regulations, including cGMP (Current Good Manufacturing Practice), labeling requirements, and safety standards. Companies that [...]
Compliance with Current Good Manufacturing Practices (cGMP) is mandatory for all pharmaceutical manufacturers, repackers, relabelers, and distributors who want to market drug products in the United States. Governed under 21 CFR Parts 210 and 211, cGMP regulations establish the minimum requirements for methods, facilities, and controls used in the manufacturing, [...]